510(k) K993064 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
| Applicant | Gambro Renal Care Products, Lakewood CO, US |
| Decision | Substantially Equivalent, Oct 6, 1999 |
| Received | Sep 13, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K993064
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2005 | Gambro Renal Products Prisma continuous renal replacement system. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.